Where is the Manufacturing Engineer II role at Freudenberg Medical based?

This role is based in Jeffersonville, IN.

How many years of experience does this Manufacturing Engineer II role require?

The posting calls for at least 3 years of relevant experience.

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Manufacturing Engineer II

Freudenberg Medical · Jeffersonville, INtoday

BS-level Process Engineering roles on Crosslinked list a median of $112k (598 that show pay). This posting does not list pay.

Optimize medical device manufacturing processes including injection molding and extrusion

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Worth knowing

Why it is interesting. Hands-on process engineering role in medical device manufacturing with injection molding and extrusion.

Might not be for you. Heavy focus on regulatory compliance and documentation (ISO, GMP, 21 CFR 820), less open-ended R&D.

Bench and deskGeneralist BS acceptable

Adjacent materials rolemanufacturing processes used in medical device production, such as running equipment, injection molding, extrusion, catheter manufacturing, and assembly, including the materials used

H-1B filings

Freudenberg Medical filed 4 H-1B labor applications for scientist and engineer roles from Jan to Dec 2025.

Most common titles: Quality Engineer II, Product Development Engineer II, Engineer. Median filed pay: $102K a year.

From U.S. Department of Labor disclosure data. A filing is a record of past hiring, not a promise about this role, so confirm sponsorship with the employer. Titles and filed pay ·Every employer's filings

Seniority: Mid-level
Work: On-site
Type: Full-time
Degree: BS
Experience: 3+ yrs
Industry: Medical devices
Role: Process Engineering

Role details

Working at Freudenberg: We will wow your world!

Responsibilities

Guide the development and optimization of manufacturing processes, including tooling design and process characterization in compliance with ISO standards, country-specific and GMP regulations. Develop and maintain detailed manufacturing documentation, including BOMs, process flowcharts, work instructions, and test/inspection plans in compliance with quality system requirements. Specify and coordinate the procurement, installation, and qualification (IQ/OQ/PQ) of manufacturing equipment, fixtures, and gauges to support efficient and reliable production.

Participate in daily production meetings (i.e., LPMS) and collaborate with operations and customer service to ensure project timelines, production goals, and cost targets are met. Proactively communicate with customers and suppliers on project matters, mold and fixture design/repair, validation, and product quality issues. Train and support technicians and operators through ongoing sustaining engineering activities. Analyze and solve manufacturing issues using a structured, root-cause problem-solving approach and lead cross-functional teams to implement robust, permanent solutions.

Lead Lean/Six Sigma projects to improve productivity, quality, delivery, and cost; oversee Kaizen initiatives and eliminate waste in manufacturing processes. May help train new team members.

Qualifications

Bachelor's/University degree in Engineering, Chemistry, Biology, or related science/technical field. 3+ years' experience in a regulated industry. Proficiency in manufacturing processes used in medical device production, such as running equipment, injection molding, extrusion, catheter manufacturing, and assembly, including the materials used. Demonstrated experience with formal problem-solving methodologies, critical thinking, and deductive skills. Thorough understanding of ISO standards, particularly ISO 13485, ISO 14001, ISO 14971.

Proficiency in GMP principles and their application in medical device manufacturing, including country-specific regulatory requirements (i.e., 21 CFR 820 in the United States). Understanding of process validation principles and process window/repeatability studies, DOE’s, IQ/OQ/PQ, and how to validate manufacturing processes to ensure consistent product quality and necessary safety protocols. Familiarity with product testing and inspection methods to ensure compliance with specifications and standards.

Ability to maintain technical documentation, including work instructions, standard operating procedures (SOPs), and production records. ‎ ‎ The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion.

Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law. Freudenberg Medical LLC